Ignite Creation Date:
2025-12-24 @ 7:34 PM
Ignite Modification Date:
2026-01-07 @ 8:38 PM
Study NCT ID:
NCT06518603
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-09-05
First Post:
2024-07-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Caffeine Citrate in Preterm Infants at Risk of Apnea in Zambia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001049', 'term': 'Apnea'}], 'ancestors': [{'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012818', 'term': 'Signs and Symptoms, Respiratory'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C026189', 'term': 'caffeine citrate'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Masking will be maintained throughout the study and only the study pharmacists will be aware of the treatment group. The study pharmacist will prepare the 28-day supply of either caffeine citrate or placebo in indistinguishable clear solutions and same vials of equivalent volumes for the infant to continue at home. All other study staff, facility staff, follow-up staff, and family members will be masked to the treatment allocation. Identical vials will be prepared for the placebo arm with only a specific code written on the vials differentiating it from caffeine citrate. This code will be known only to the study pharmacist. Caffeine levels will not be checked routinely and checking levels will be discouraged to optimize masking.'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Double blind, placebo-controlled, 1:1 parallel allocation'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 340}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-01-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-04', 'studyFirstSubmitDate': '2024-07-18', 'studyFirstSubmitQcDate': '2024-07-18', 'lastUpdatePostDateStruct': {'date': '2025-09-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-07-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of apneic events', 'timeFrame': '28 days after discharge', 'description': 'Documentation or report of apnea of prematurity \\[AoP\\], a condition exhibited by cessation of breathing for ≥20 or \\<20 seconds accompanied by bradycardia and/or cyanosis'}, {'measure': 'Number of visits to healthcare professionals related to apneic events', 'timeFrame': '28 days after discharge', 'description': 'Documentation or report of sick visit'}], 'secondaryOutcomes': [{'measure': 'Number of all-cause sick visits', 'timeFrame': '2 months after discharge', 'description': 'Documentation or report of sick visit'}, {'measure': 'Percentage of neonatal mortality within 2 months after discharge', 'timeFrame': '2 months after discharge', 'description': 'Documentation of neonatal death'}, {'measure': 'Infant/Child Developmental Assessment', 'timeFrame': '12 months', 'description': 'Score on "Ages and Stages Questionnaire" obtained at clinic visit'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Premature Infant Disease', 'Apnea of Prematurity', 'Development, Infant']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to learn if caffeine citrate prevents apneic events that result in sick visits in moderately preterm infants after discharge from the hospital. It will also learn if the use of caffeine leads to better developmental outcomes at 12 months of age.\n\nOur research questions are:\n\n1. Does continued treatment of moderately preterm newborns with caffeine citrate after hospital discharge prevent or decrease apneic events that result in sick visits?\n2. Will the continued use of caffeine citrate lead to improved developmental outcomes among infants at 12 months of age?\n\nResearchers will compare caffeine citrate to a placebo (a look-alike substance that contains no drug) to see if caffeine citrate prevents apneic spells which result in healthcare visits.\n\nParents of participants will:\n\n1. Administer caffeine citrate 20mg/kg/day or a placebo (equivalent volume of sterile water) orally every day for up to 28 days after hospital discharge\n2. Keep a diary of symptoms and any apneic events\n3. Check in with researchers via telephone call once a week\n4. Return to clinic for infant physical examination at 28 days\n5. Return to the clinic for infant physical examination at 2 months\n\n5\\. Return to clinic for infant neurodevelopmental examination with Ages and Stages Questionnaire at 12 months of age', 'detailedDescription': "Once an infant has been deemed stable by the neonatologist and the neonatologist recommends discontinuing treatment for apnea of prematurity 5 days before hospital discharge as per standard of care, the parent/guardian will be approached for consent. Following consent, study participants will be randomized to either the Intervention Arm (20mg/kg/day caffeine citrate; 2mg/ml) dose and equal volume of placebo (sterile water) using trial-specific single dose caffeine/placebo vials. Upon the study participant's hospital discharge, the pharmacist will prepare the caffeine citrate and placebo relevant to the weight of the infant within 48 hours prior to discharge. The doses will not be adjusted for weight gain after discharge. Caffeine levels will not be checked routinely and checking levels will be discouraged to optimize masking.\n\nWhile at the hospital, infants will receive the oral dose from government staff. Following hospital discharge, the parent/guardian will be given enough doses of caffeine or equivalent placebo for 28 days and will be asked to administer it to their infant orally daily, at the same time, until day 28. Unlike the intervention arm, all study participants randomized to the control arm (placebo) will discontinue receiving caffeine and will begin receiving placebo (sterile water) in the same volume orally as those in the intervention arm. The parent/guardian will also be given a booklet to register any apneic spells. The study RA will contact the parent/guardian on a weekly basis, up to day 28 and once at 2 months after hospital discharge for patient clinical monitoring and follow-up purposes.\n\nUpon completion of the study at 12 months of life, all study participants will return to the hospital for neurodevelopmental screening using the Ages and Stages-3 Questionnaire for 12 months.\n\nData will be collected onto paper forms, which will then be entered into a REDCap Database, housed at the Centre for Infectious Disease Research in Zambia (CIDRZ) offices. Data forms will be kept in locked cabinets, retained and destroyed per incineration after 5 years. Access to the data forms and REDCap Database will be restricted to those with a need to know."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Months', 'minimumAge': '0 Days', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nNewborns:\n\n1. 29 0/7 to 33 6/7 weeks GA (or with a birth weight 1.0 to 2.0 kg if pregnancy dating is unreliable) admitted to the UTH NICU,\n2. On methylxanthines with plans to discontinue on methylxanthine,\n3. Off oxygen therapy for \\>48 hours at the time of evaluation for eligibility,\n4. Receiving full daily feeds,\n5. Deemed stable and ready to go off caffeine as recommended by the Neonatologist\n6. 18+ years of age (parent)\n\nExclusion Criteria:\n\n1. Newborns with neuromuscular conditions affecting respiration,\n2. Major congenital malformations and genetic disorders,\n3. Unable to obtain parental or guardian consent'}, 'identificationModule': {'nctId': 'NCT06518603', 'briefTitle': 'Caffeine Citrate in Preterm Infants at Risk of Apnea in Zambia', 'organization': {'class': 'OTHER', 'fullName': 'University of Alabama at Birmingham'}, 'officialTitle': 'Randomized Controlled Trial of Caffeine Citrate in Preterm Infants at Risk of Apnea in Zambia', 'orgStudyIdInfo': {'id': 'UAB-300013205'}, 'secondaryIdInfos': [{'id': 'UAB Dixon End Chair/3102800', 'type': 'OTHER', 'domain': 'University of Alabama at Birmingham'}, {'id': '000533428-0004', 'type': 'OTHER', 'domain': 'INSIGHT'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Oral Caffeine Citrate 20mg/kg/day', 'description': 'Caffeine Citrate 20 mg/kg/day given orally once a day for 28 days. (2mg/ml)', 'interventionNames': ['Drug: Caffeine citrate 20mg/kg/day']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Sterile water 1ml/kg/day given orally once a day for 28 days.', 'interventionNames': ['Drug: Placebo-Sterile water 1ml/kg/day']}], 'interventions': [{'name': 'Caffeine citrate 20mg/kg/day', 'type': 'DRUG', 'description': 'Caffeine citrate 20mg/kg/day given orally once daily for 28 days', 'armGroupLabels': ['Oral Caffeine Citrate 20mg/kg/day']}, {'name': 'Placebo-Sterile water 1ml/kg/day', 'type': 'DRUG', 'description': 'Placebo-sterile water 1mg/kg/day given orally once daily for 28 days', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10100', 'city': 'Lusaka', 'state': 'Lusaka Province', 'country': 'Zambia', 'contacts': [{'name': 'Albert Manasyan, MD', 'role': 'CONTACT', 'email': 'Albert.Manasyan@cidrz.org', 'phone': '+260 976 448 994'}, {'name': 'Waldemar A Carlo, MD', 'role': 'CONTACT', 'email': 'wacarlo@uabmc.edu', 'phone': '2059344680'}, {'name': 'Jyoti Lakhwani, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University Teaching Hospital', 'geoPoint': {'lat': -15.40669, 'lon': 28.28713}}], 'centralContacts': [{'name': 'Albert Manasyan, MD', 'role': 'CONTACT', 'email': 'Albert.Manasyan@cidrz.org', 'phone': '+260 976 448 994'}, {'name': 'Waldemar A Carlo, MD', 'role': 'CONTACT', 'email': 'wacarlo@uabmc.edu', 'phone': '2059344680'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Alabama at Birmingham', 'class': 'OTHER'}, 'collaborators': [{'name': 'University Teaching Hospital, Lusaka, Zambia', 'class': 'OTHER'}, {'name': 'Centre for Infectious Disease Research in Zambia', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Albert Manasyan, MD, MPH', 'investigatorAffiliation': 'University of Alabama at Birmingham'}}}}